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The global market for transcatheter treatment of the mitral and aortic valves is expected to double over the next five years, according to a new report from BCC Research. The industry analysis projects an increase from $4 billion in 2018 to $8 billion in 2023, at a compound annual growth rate (CAGR) of 14.8 percent.

Transcatheter mitral valve repair (TMVR) accounted for just 12 percent of transcatheter aortic or mitral procedures in 2017, according to the report, but are expected to grow faster over the next few years than the more established field of transcatheter aortic valve replacement (TAVR). In 2023, BBC research predicts TMVR will account for 22 percent of the segment while TAVR will claim the other 78 percent—down from 88 percent in 2017.

“The burden of chronic diseases such as arterial disease, hypertension, obesity/diabetes, and other heart-related disorders is rapidly increasing in both developed and developing nations and is fueling market growth,” the report stated. “In addition to a large disease population, shorter recovery time, and shorter hospital stays, favorable outcomes with TAVR and TMVR and technological advancements are also driving the adoption of transcatheter heart valve devices.”

But market barriers exist as well, according to BCC Research analyst Ritu Thakur Dangi, BAMS, who authored the report. The high cost of heart valves, concerns over the surveillance and long-term durability of artificial valves, reimbursement issues and regulatory approval processes could hamstring growth, she told Cardiovascular Business in an email.

“Achieving statistically significant outcome from clinical trials and getting an approval for complex and challenging primary as well as secondary indications is the major challenge for now,” she said. “I think it should have a close watch over the next few years as most of the companies are struggling to get statistically significant data from ongoing clinical trials along with required positive clinical outcome.”

Here are three other notable takeaways from the report:

1. A few players dominate the space.

Even though more companies are looking to break into the TAVR/TMVR space, Edwards Lifesciences (55 percent), Medtronic (29 percent) and Abbott (14 percent) combined to share about 98 percent of the market in 2017. And those device makers are taking steps to maintain that stranglehold.

“All of the market leaders have focused on merger and acquisition (M&A) activities and have strengthened their market position through acquisitions, minority investments, and financing activities to be in the position to buy targeted early-stage companies,” according to the report.

Abbott is well-positioned in the TMVR sector thanks in part to its MitraClip device and the positive results from the 2018 COAPT trial. MitraClip is currently only FDA-approved for degenerative mitral regurgitation but expanding the label to those with secondary MR could open the treatment to another 300,000 to 500,000 COAPT-like patients in the U.S., a trial co-author recently told Cardiovascular Business.

“Abbott’s MitraClip alone is making sales of nearly $500-600 million and expected to reach around $2 billion sales by 2025,” Dangi wrote in the email. “Edwards Lifesciences is the close competitor and struggling to generate (a) few million (in) sales by the end of this year. However, device development and plans seems to be promising and Edwards is expected to make nearly $600-$700 million sales by 2025.”

2. TAVR’s progression to a lower-risk population will drive some of its growth.

The procedure began as an alternative therapy for patients deemed at prohibitive risk of open surgery and has now been studied in patients at high and intermediate surgical risk. At the upcoming American College of Cardiology scientific sessions in March, two late-breaking trials will evaluate TAVR versus surgery in low-risk patients.

If the treatment continues to demonstrate efficacy in increasingly lower risk populations, it would obviously have huge implications for the TAVR market overall, given many patients’ preference for the less-invasive option. Dangi said she factored these risk-group considerations into her market analysis, noting the contributions of low and intermediate-risk patients to the market are “way low for now” but are expected to comprise more than 25 percent of the market in the next six to eight years.

3. The U.S. will remain the top provider of transcatheter heart valve treatments.

The U.S. will continue to drive more than half of the market, reaching $4.8 billion of the projected $8 billion by 2023, according to the report. Europe is expected to be the second-largest market, while Asia will witness the fastest growth due to its expanding aging population, growing acceptance of transcatheter procedures, increased availability and affordability of treatment and advanced technology products and solutions.

Japan is already an established market for transcatheter heart treatments, while China and India are emerging and “growing rapidly,” Dangi wrote.